Is HEPA filters required to install for air supply in areas of non-sterile dosage forms?
No, HEPA filters does not specifically require manufacturing facilities for non-sterile drugs to maintain HEPA filtered air. The Regulations do require the... Read More
What is the meaning of Pharmaceutical Profiling?
Pharmaceutical profiling assays helps to measure the properties of large numbers of drug candidates at the earliest stages of discovery. It is... Read More
What is USFDA Tentative Approval?
If a generic drug product is ready for approval before the expiration of any patents or exclusivities accorded to the reference listed... Read More
How to calculate compound annual growth rate (CAGR)?
Posted on29 Feb 2024
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The compound annual growth rate (CAGR) is a useful measure of growth over multiple time periods. It can be thought of as... Read More
What is 351(k) biologics license application (BLA)?
Posted on29 Feb 2024
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351(k) biologics license application is the biosimilar application process in USFDA. Manufacturers must submit 351(k) biologics license application (BLA) to have a product... Read More
What are the key factors which affect royalty rate in pharmaceutical industry?
Determining the ideal royalty payment in the pharmaceutical industry is complex and depends on various factors. Some key considerations include: Market Value:... Read More
How much is the ideal royalty payment in pharmaceutical industry?
A royalty payment is made to the legal owner of the property, patent, copyrighted work, or franchise by licensees or franchisees who... Read More
What are the difference between Wholesaler and Specialty Pharmacy?
Posted on21 Feb 2024
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There are clear cut difference between the two terms. The wholesalers are the first purchaser of the drug, directly from manufacturer. Specialty... Read More
A case based understanding in co-development deal
Posted on21 Feb 2024
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In a Co-Development Agreement the intellectual property is typically licensed by the licensor to the alliance partner, and as well, the two... Read More
Differences between the Laboratory Pilot and Commercial Scale
Posted on17 Oct 2023
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There are three different types of scale of operation in pharmaceutical manufacturing. Let us explore the differences between each of these scales.... Read More